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Boston,
Massachusetts

Purpose:

Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with
multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies
and without further established treatment options.

Study summary:

This study is conducted in two parts. In part I, participants are enrolled into cohorts at
increasing dose levels. Participant safety and efficacy during part I will determine the
doses used for Part II. In part II participants will be enrolled into one of two sequential
treatment arms using two of the doses defined in part 1 of the study. Part II was 5 cohorts,
3 with 8 milligram per kilogram (mg/kg) and 2 with 16 mg/kg. Part I and all but the last
cohort in Part II were dosed with Phase 1/ 2 drug product. The last cohort in Part II was
dosed with Phase 3 drug product. Both Part I and Part II are open-label/unmasked.

Criteria:

Inclusion criteria
- Diagnosis of multiple myeloma (MM) requiring systemic therapy
- Age greater than or equal to (>=) 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy greater than (>) 3 months
- Relapsed from or refractory to two or more different prior therapies
- Signed Informed consent
Exclusion criteria
- Plasma cell leukemia defined as a plasma cell count > 2000/millimeter^3 (mm^3)
- Known amyloidosis
- Participants who previously have received an allogeneic stem cell transplant
- Sensory or motor neuropathy of >= grade 3
- Past or current malignancy
- Chronic or ongoing active infectious disease
- Clinically significant cardiac disease
- Significant concurrent, uncontrolled medical condition including, but not limited to,
renal (except related to MM), hepatic, hematological except MM, gastrointestinal,
endocrine, pulmonary, neurological, cerebral or psychiatric disease
- A baseline QT interval as corrected by Fridericia's formula > 470 millisecond (msec)
for female participants or > 450 msec for male participants or a complete left bundle
branch block (defined as a QRS interval >= 120 msec in left bundle branch block form)
- Hypokalemia
- Clinical signs of meningeal involvement of MM
- Known severe chronic obstructive pulmonary disease or asthma defined as forced
expiratory volume in 1 second (FEV1) less than (<) 60 percentage (%) of expected
- History of significant cerebrovascular disease
- Known Human Immunodeficiency Virus seropositivity
- Positive serology for hepatitis B
- Screening laboratory values
- Concomitant corticosteroid
- Other chemotherapy that is or may be active against myeloma within 3 weeks prior to
Visit 2 (Part 1) or the first dose of daratumumab (Part 2). However, corticosteroid
for myeloma (less than a 4-day course) could be administered within 1 week before
Visit 2 (Part 1) or the first dose of daratumumab (Part 2)
- Known hypersensitivity to components of the investigational product or severe
allergic or anaphylactic reactions to humanized products
- Participants who have received treatment with any nonmarket drug substance within 4
weeks before the first dose of daratumumab
- Current participation in any other interventional clinical trial
- Participants known or suspected of not being able to comply with a trial protocol
(example, due to alcoholism, drug dependency, or psychological disorder)
- Breastfeeding women or women with a positive pregnancy test at Screening
- Women of childbearing potential not willing to use adequate contraception, defined as
hormonal birth control or intrauterine device, during the trial and for 1 year after
the last dose of daratumumab. For participants in the United States, the use of a
double-barrier method is also considered adequate